A Pilot Study of Bovine Lactoferrin in Patients With Colorectal Carcinoma Receiving Oxaliplatin-Based Chemotherapy and Self-Reported Taste Disturbances
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses
研究概览
简要总结
The purpose of this research study is to determine if using a lactoferrin supplement will improve taste perception. Lactoferrin is a type of protein that is naturally produced in the body and is commonly found in saliva.
详细描述
PRIMARY OBJECTIVES:
I. To assess the impact of lactoferrin (bovine lactoferrin) supplementation on self-reported taste and smell disturbances in patients with colorectal cancer receiving oxaliplatin-based chemotherapy
SECONDARY OBJECTIVES:
I. To assess the impact of lactoferrin supplementation on the baseline lipid peroxidation byproducts in saliva in these patients as measured by the thiobarbituric acid-reactive substances (TBARs) assay.
II. To assess the impact of lactoferrin supplementation on the ability of these patients to generate increased lipid peroxidation byproducts when challenged with a weak iron containing solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically confirmed colorectal carcinoma
- •There are no restrictions on the amount or types of prior therapy
- •Eligible patients must be receiving ongoing chemotherapy with an oxaliplatin containing-regimen which is planned to continue for at least one month following enrollment in this trial
- •Any dose or schedule of oxaliplatin administration is allowed as long as patients have self-reported taste disturbance that has either:
- •developed since the initiation of oxaliplatin-based therapy, or
- •a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating oxaliplatin-based therapy
- •Patients must have normal baseline self-reported taste perception prior to the development of colorectal carcinoma
- •Life expectancy of >= 3 months
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients with a subjective history of an extreme dry mouth syndrome that prevents them from producing adequate amounts of saliva (approximately 2 mL in 15-20 min)
- •Patients known to be human immunodeficiency virus (HIV)-positive
- •Patients with any of the following conditions: untreated gastrointestinal reflux disease; untreated diabetes mellitus; active thrush; active oral infection; active mucositis
- •Patients who are known to be pregnant or who are breastfeeding are excluded
研究组 & 干预措施
Supportive care (bovine lactoferrin)
Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity.
干预措施: questionnaire administration (Other)
Supportive care (bovine lactoferrin)
Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity.
干预措施: quality-of-life assessment (Procedure)
Supportive care (bovine lactoferrin)
Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Supportive care (bovine lactoferrin)
Patients receive bovine lactoferrin PO (rinse or tablet) TID for 1 month. Treatment continues in the absence of unacceptable toxicity.
干预措施: bovine lactoferrin (Dietary Supplement)
结局指标
主要结局
Change in the Taste Visual Analog Scale (VAS) and taste and smell questionnaire responses
时间窗: Approximately 1 month
Paired-tests will be used to assess the significance of these changes. Linear regression models will be used to determine which patient covariates are associated with change. Repeated measures models will also be used to assess the changes over time using all the repeated measures and contrasts will be used to assess individual pair-wise differences. Descriptive reports will consist of summary statistics (means, standard deviations, proportions, etc.).
次要结局
- Effect of bovine lactoferrin on lipid peroxidation byproducts in saliva as measured by the TBARs assay(Approximately 2 months)
- Malondialdehyde (MDA) concentrations before and after a ferrous iron oral rinse(Approximately 2 months)
- Quality of life as quantified by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire(Approximately 2 months)